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Completed

NCT Number: NCT06207474

A Study on BReast Cancer Patient Care Using chAtbot and Video Education for Radiation Therapy (BRAVE)

This randomized trial explored whether digital media (videos and chatbots) used for patient education could more effectively reduce anxiety in breast cancer patients during radiation therapy, compared to traditional paper-based methods. Post-surgery breast cancer patients scheduled for radiation therapy were assigned to groups receiving treatment information through different media combinations. The study aimed to assess whether these modern tools more effectively ease anxiety, thus potentially improving patient compliance and treatment experience.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei Cancer Center

Seoul, South Korea

About this study

This study evaluates the impact of patient management and information provision using educational videos and chatbots on patient experience, satisfaction, and patient psychology in the breast cancer radiation treatment process.

The experiment is designed as (2 (with or without using chatbot) X 2 (with or without using video) to distinguish groups.

There is no separate treatment intervention in addition to use chatbot and video utilization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A breast cancer patient scheduled for radiation therapy after radical surgery.
  • Subjects must have the cognitive ability to use smartphone.
  • Age ≥ 20 year old

Exclusion criteria

  • Patients with visual or auditory impairment.
  • Subjects do not consent to participate in this study.
  • Pregnancy, fetus, newborn, underage
  • Age ≥ 75 year old

Treatment and study plan

Video + Chatbot

Other

Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of educational videos and interactive chatbot sessions.

Video + Paper

Other

Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of educational videos and paper materials.

Paper + Chatbot

Other

Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of paper materials and interactive chatbot sessions.

Paper + Paper

Other

Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using paper materials.

Primary outcomes

  1. APAIS(Amsterdam Preoperative Anxiety and Information Scale)

    Time frame: baseline, before radiation therapy, after all radiation, an average of 1 month

    The Amsterdam Preoperative Anxiety and Information Scale (APAIS): The APAIS consists of six self-reported items, primarily assessing anxiety associated with anesthesia and surgery.

Secondary outcomes

  1. STAI-X(State-Trait Anxiety Inventory for Adults)

    Time frame: baseline, before radiation therapy, after all radiation, an average of 1 month

    The STAI is a widely recognized self-report instrument for gauging anxiety levels.

  2. LASA(Linear Analog Scale Assessments)

    Time frame: baseline, before radiation therapy, after all radiation, an average of 1 month

    LASA is a tool to measure a patient's self-assessment of various aspects of their health and wellbeing.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2024
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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